Clinical trial · Interventional
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
A Multicenter Medical Safety Follow-up Study for Patients With Partial Onset Seizures Who Received More Than 28 Days of Total Exposure to BGG492 in Studies CBGG492A2207 and/or CBGG492A2212
NCT02150213CI-TRIAL-00024997completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Adenoma | Adrenal Cortical Adenoma | ALIAS | 0.90 |
| Endometrial Stromal Sarcomas | Endometrioid Stromal Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGG492 | Drug | — | UNRESOLVED |
| Biopsy | Procedure | — | UNRESOLVED |
| Dexamethasone Supression Test | Procedure | — | UNRESOLVED |
| MRI, CT or ultrasound was permitted if MRI was contraindicated | Procedure | — | UNRESOLVED |
| Sonogram | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGG492
- description
- This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
- interventionNames
- Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
- Procedure: Dexamethasone Supression Test
- Procedure: Sonogram
- Procedure: Biopsy
- Drug: BGG492
Primary outcomes (2)
- measure
- Incidence of Adrenal Cortical Adenomas
- timeFrame
- Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
- description
- Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent had to be obtained before any assessment was performed; 2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events; 3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days 4. At least 1 year had to have elapsed since the patient received his or her last dose of BGG492. Exclusion Criteria: \- There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments
References
Publications (0)
Data not yet available
No reference posted for this study.